HAPEX MALLEABLE TORP— 510(k) K950927
Substantially EquivalentSmith & Nephew Richards, Inc.
FDA 510(k) clearance K950927 for HAPEX MALLEABLE TORP, Substantially Equivalent on 1995-03-21. Applicant: Smith & Nephew Richards, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew Richards, Inc.
- Product code
- Code ETA
- Device class
- Class 2
- Regulation
- 21 CFR 874.3495
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bartlett, TN, US
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